INDICATION for ALVESCO (ciclesonide) INHALATION AEROSOLALVESCO is indicated for the
maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and
older. ALVESCO is NOT indicated for the relief of acute bronchospasm. ALVESCO is NOT indicated for children
under 12 years of age.

IMPORTANT SAFETY INFORMATION for ALVESCOALVESCO is contraindicated in the primary
treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips,
tongue, and pharynx, have been reported.

The development of localized infections of the mouth and pharynx with Candida albicans have occurred
infrequently. When such an infection develops, it may be necessary to interrupt therapy with ALVESCO.

Patients who are using immunosuppressant doses of corticosteroids are more susceptible to infections than
healthy individuals. Chicken pox and measles can have a more serious or even fatal course in susceptible
individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or
quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial
infections, systemic viral or parasitic infections; or ocular herpes simplex because of the potential for
worsening of these infections.

Particular care is needed for patients who are transferred from systemically active corticosteroids due to the
potential for adrenal insufficiency. Patients should taper slowly from systemic corticosteroids if switching to
ALVESCO.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear
in a small number of patients particularly when ALVESCO is administered at higher than recommended doses over
prolonged periods of time. If such effects occur, the dosage of ALVESCO should be reduced slowly, consistent
with accepted procedures for reducing systemic corticosteroids and management of asthma.

Decreases in bone mineral density have been observed with long-term administration of inhaled corticosteroids.
Patients with major risk factors for decreased bone mineral content should be monitored.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of
inhaled corticosteroids including ALVESCO. Patients with a change in vision or with a history of increased
intraocular pressure, glaucoma, and/or cataracts should be closely monitored.

If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting
inhaled bronchodilator.

The most common adverse reactions in clinical trials were headache, nasopharyngitis, sinusitis,
pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity, and back
pain.

To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.